Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.

INTRODUCTION: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. AIM: Expanding information on LC efficacy and safety. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). METHODS: A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. RESULTS: IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. CONCLUSIONS: LC showed a satisfactory efficacy-safety profile for oral therapy of ED.

Efficiency of 6- and 12-punctures biopsies to detect prostate cancer in patients with PSA< 10 ng/mL and normal digital rectal examination

OBJECTIVE: Establish the efficiency of 6- and 12-punctures transrectal ultrasound-guided needle biopsies in low risk patients for prostate cancer. Six-punctures (sextant) biopsies were compared to 12-punctures biopsies, assessing which is the best strategy to detect this neoplasm. MATERIALS AND METHODS: Among 240 patients submitted to prostate biopsy, 54 with suspected small and organ-localized tumors (prostatic specific antigen < 10 ng/mL and digital exam of the prostate not suggesting cancer) in glands < 50 cm³ were selected, constituting a homogenous sample. These patients were submitted to standard 3-punctures (basal, mid, and apical) sextant biopsy in parasagittal midline of each prostatic lobe, with 3 additional lateral punctures, bilaterally. Each specimen was separately submitted to histological study. RESULTS: Twenty-two (40.7 percent) patients had prostatic cancer, and 28 presented prostatic hyperplasia, associated or not to inflammatory conditions. High-grade prostatic intraepithelial neoplasia (PIN) was detected in 4 patients. From 22 tumors detected by 12-punctures biopsies, 6-punctures biopsies in the parasagittal midline (sextant) diagnosed 50 percent of the cases, while isolated lateral punctures diagnosed 90.9 percent of the malignant neoplasms. Basal lateral punctures responded for 72.7 percent of the cancer diagnosis, while basal sextant punctures responded only for 9.1 percent of the cases. CONCLUSION: For low risk prostate cancer, patientsÆ 12-punctures biopsy was more effective, for sextant biopsy failed to diagnose half of the cases of neoplasm. Three lateral punctures (basal, mid, and apical), with 2 additional punctures in the parasagittal midline (mid and apical) bilaterally are suggested as the best biopsy strategy

Efficiency of 6- and 12-punctures biopsies to detect prostate cancer in patients with PSA

OBJECTIVE: Establish the efficiency of 6- and 12-punctures transrectal ultrasound-guided needle biopsies in low risk patients for prostate cancer. Six-punctures (sextant) biopsies were compared to 12-punctures biopsies, assessing which is the best strategy to detect this neoplasm. MATERIALS AND METHODS: Among 240 patients submitted to prostate biopsy, 54 with suspected small and organ-localized tumors (prostatic specific antigen